Senior Safety Data Scientist

This is a fully remote position, open to applicants in New Jersey.

📋 Description

• Collaborate with various stakeholders to enhance product safety profiles and conduct benefit-risk evaluations throughout the entire product lifecycle.

• Execute signal detection and signal evaluation while preparing written and verbal reports on signal management activities and patient safety concerns.

• Carry out routine surveillance tasks by analyzing safety data from clinical studies, safety databases, and relevant literature.

• Work alongside safety and clinical teams to formulate strategies for signal evaluations and regulatory inquiries.

• Examine data from diverse sources to assist in signal assessments and address ad hoc regulatory safety requests.

• Utilize medical expertise to evaluate the influence of safety issues on the benefit-risk profiles of compounds or products.

• Present findings from surveillance and safety assessments to product teams and leadership, including suggestions for risk mitigation and label modifications.

• Jointly prepare and update safety sections of Clinical Summary of Safety, Clinical Study Reports, Company Core Data Sheets, and Risk Management Plans.

• Assist in the creation, authorship, and review of global aggregate safety reports under supervision.

• Compile essential safety data summaries for product safety, senior reviews, senior management, Advisory, and similar meetings under supervision.

⛳️ Requirements

• A degree in a Health Sciences discipline, such as Pharmacy, Epidemiology, or Nursing.

• A Bachelor's degree accompanied by 2 years of experience in clinical, pharmaceutical, or safety roles.

• A Master's or Doctorate with 1–2 years of experience in clinical, pharmaceutical, or safety positions (e.g., MPH, PharmD, PhD, or a Master's in a Health Science).

• Proficiency in the drug development process, encompassing clinical trials, scientific strategy, operations management, regulatory submissions, product launches, and post-marketing support.

• Strong understanding of pharmacovigilance regulations, guidelines, and company standard operating procedures.

• Comprehensive knowledge of compounds within designated therapeutic areas, including safety profiles, labeling, literature, and regulatory issues as applicable.

• Familiarity with tools, standards, and methodologies for effective drug safety evaluation is preferred but not mandatory.

• Experience in multidisciplinary, matrix team environments.

• Excellent oral and written communication abilities.

• Capability to manage multiple projects at once.

• Proficiency in Microsoft Word and Excel.

• Basic project management skills.

• Ability to work independently with guidance from a manager.

🏝️ Benefits

• Paid time off, which includes vacation, holidays, and sick leave.

• Medical, dental, and vision insurance coverage.

• 401(k) retirement plan.

• Eligibility to participate in long-term incentive programs.